USFDA nods to desi drugs up 84% in 1 yr

India has become a dominant player in the US generics space with a large number of plants and increased scale of operations, exporting key drugs and injectables from the country.June 28, 2016, 08:08 IST

Mumbai: Drug approvals given by the US Food and Drug Administration (USFDA) to Indian companies nearly doubled year-on-year, with little-known firms including MSN Lab, Shasun Pharma, Granules India, Ajanta Pharma and Gland Pharma making a foray into the world's biggest and most lucrative market. Interestingly, the growth came during the period when biggies like Sun Pharma and Dr Reddy's had reduced filings from their plants due to compliance issues, dispelling the long-held view that regulatory agencies, particularly USFDA, harboured a vendetta against the domestic industry.

Over the last couple of years, companies have faced intense regulatory glare from the US, with nearly all the top pharma players having been issued warning letters over manufacturing violations at their plants. This led some to believe that they were being singled out for action - most of this was triggered after the erstwhile Ranbaxy (now part of Sun Pharma) faced regulatory woes.

Companies which have USFDA-approved plants apply for regulatory clearance for launching generic drugs in the US market. Overall approvals increased from 109 in FY2014-15 to 201 for the period April to March 2016 - up by 84%, an analysis of USFDA approvals showed. Aurobindo, Lupin and Glenmark led with 50, 27 and 18 approvals respectively in FY 2015-16, as against Sun Pharma (14), Lupin (10) and Jubilant, Hetero Labs and Macleods at 8 each in the previous year. The list showed that certain companies were first-timers (in terms of approvals), while many were of specialised treatments.

India accounts for around 30% (by volume) and about 10% (value) in the $70-80 billion US generics market. Over the years, India has become a dominant player in the US generics space with a large number of plants and increased scale of operations, exporting key drugs and injectables from the country.

Industry experts say with the growing level of exports (to US) of generic drugs in recent years, the number of USFDA inspections of manufacturing plants has also risen. The number of Indian companies supplying to the US market have jumped by nearly three times now, as against only a handful five years back.

"The increase in number of approvals is partly due to GDUFA (Generic Drug User Fee Act) under which the FDA had agreed to expedite the processing of ANDAs, and partly due to the importance of drugs and inadequate competition," D G Shah, secretary general of Indian Pharmaceutical Alliance, said. ANDAs refer to abbreviated new drug applications.

The GDUFA helped the USFDA to clear almost 90% of the approvals backlog. Some of the high-value approvals that Indian firms received were reportedly for generic versions of Otsuka's Abilify (aripiprazole) used for treating schizophrenia; Vigamox (moxifloxacin), a conjunctivitis drug made by Novartis company Alcon; Zetia (ezetimibe), a drug prescribed for treating hypertension made by MSD; and anti-cancer drug Gleevec (imatinib) made by Novartis.

Glenmark Pharmaceuticals CMD Glenn Saldanha said, "During the financial year 2015-16, we received a significant number of approvals from USFDA. The company received a total of 24 approvals (including tentative nods), which is the highest ever for the company. Because of this, our US business has gained good traction in FY2015-16."